Regulatory affairs

Services offered: Informing clients about applicable laws and regulations Professional scientific and medical translations Submission of registration documentation for placing the finished drug on the market (MA) on behalf of the client Submitting a request for the renewal or amendment of the approval for placing the finished drug on the market and/or changes in the documentation on the drug The request is accompanied by information and documents in accordance with the laws and regulations on the procedure and method of approval of medicines, depending on whether it is registration, renewal or amendment of approval Continuous monitoring of the registration process until the decision on granting approval for placing the finished medicine on the market Application for registration of a medical product in the register of medical products and submission of information on medical products Preparation of technical document Before placing a medical product on the market, the manufacturer must have a certificate from a notified body for conformity assessment for that product and a “CE” mark. The technical document is an integral part of the documentation required by the notified body The technical document must contain all the information necessary for the conformity assessment procedure, i.e. direct or indirect determination of the fulfillment of the corresponding requirements related to a specific product. Particular importance is attached to the risk assessment and clinical evaluation report of the medicinal product.